Abstract
Introduction
Breast cancer survivors (BCS) often experience side effects such as the fatigue, sleep disturbance and depression symptom cluster (FSDSC). Previous studies have demonstrated the potential efficacy of Tai Chi (TC) for improving FSDSC in BCS in a hospital setting in China. This study will explore the feasibility, acceptability and preliminary effects of the Easy 8 Form TC protocol as an adjuvant therapy in BC survivorship care, adapted to a regional Australian community setting.
Methods and analysis
The purpose of the present study is to provide a codesigned TC protocol. This multimethod study comprises a codesign study, followed by a pilot study of the adapted TC protocol. In stage 1, women with lived experience of breast cancer and community-based healthcare providers will be involved with the codesign study. The transcripts from the focus group, interviews and workshop will be thematically analysed to inform adaptations to the TC protocol to fit into the local primary health sector. Stage 2 will be a small prospective pilot study with a group of BCS trialling the adapted TC intervention. The primary outcomes of the trial are the feasibility and acceptability of TC for BCS. The secondary outcomes are clinical measures of fatigue, sleep disturbance, depression and quality of life, which will be collected from the participants of the pilot study for pre-post comparison. The findings from this study will inform stakeholder participation in codesign research with BCS. The findings will also benefit further iterations of the TC intervention, as future research continues exploring the health effects of TC.
Ethics and dissemination
Ethical approval was granted by Charles Darwin University Human Research Ethics Committee. Results will be reported in the trial registry and disseminated to participants via a peer-reviewed journal.
Trial registration number
ACTRN12626000050358 Australian New Zealand Clinical Trials Registry.
Keywords: Fatigue, Quality of Life, Breast tumours, Patient Participation, Cancer Survivors, Clinical Protocols
STRENGTHS AND LIMITATIONS OF THIS STUDY.
The short duration of the pilot trial is unable to capture long-term impacts of Tai Chi (TC), which could be investigated in future longer-term studies.
The exclusion of caregivers from the pilot trial may limit the Breast cancer survivors’ motivation to attend classes and practise TC at home.
The design will align the adaptations with the preferences of the end-users.
Feasibility and acceptability study will inform future potential full-scale randomised controlled trial.
Exploring how to develop support for rural survivors who are currently underserved by existing services.
Introduction
Breast cancer (BC) is the most common form of cancer in women,1 with the incidence in Australia expected to grow by around 16% over the next 10 years to 23775 in 2035, in line with the age-related increased risk of cancer, as well as the rapidly ageing population.2 Women are now twice as likely to survive the illness compared with 30 years ago,1 leading to a rapidly expanding cohort of breast cancer survivors (BCS). A BC survivor in this study is defined as a person who has had a diagnosis of BC and who has completed chemotherapy treatment for at least 1 month.
More women are surviving a BC diagnosis due to earlier detection and advances in treatment, with the 5-year survival rate for stages I to III BCS at 90%.3 However, the impact of treatment on their quality of life (QoL) and management of long-term solutions does not seem to have improved. Australia’s population is spread across the continent, with 7 million (28%) living in regional, rural and remote locations outside metropolitan centres.4 Post-treatment information is often lacking for rural cancer survivors in Australia, including information on healthy lifestyle choices and referrals to support services for lifestyle changes.5 Rural BCS were 30% more likely to have poorer psychological well-being than their urban counterparts.6 The burden on the community and healthcare system is measured as years lost to disability (YLD). In Australia, the disease burden of BC in women is estimated to be 11 298 YLD in 2024.7
Systematic reviews of BCS studies have shown the fatigue, sleep disturbance and depression symptom cluster (FSDSC) as the most common symptom cluster observed in BC patients at all stages of treatment.8 9 FSDSC reduces QoL, as the interactions among the symptoms increase individual symptom severity,10 leading to poorer health, financial burden, emotional distress and reduced functional capacity.11 One study found that the FSDSC was experienced by 84.4% of women with early-stage BC who received adjuvant chemotherapy.12 The symptom cluster profile may change over time, with fatigue, pain and sleep disturbance remaining after chemotherapy has been completed.13 14
Treatment guidelines for BC symptom clusters have not yet been identified, although research into nurse-led multimodal interventions appears promising.15 16 Ongoing research supports non-pharmacological interventions as being beneficial and the preferred way to manage the range of BC symptom clusters.17 Although encouraging evidence is emerging for non-pharmacological interventions for FSDSC, the quality of research is suboptimal due to small sample sizes, heterogeneity of interventions and methodologies.18
Tai Chi (TC) is a promising gentle exercise for BC rehabilitation recommended by the Australian Cancer Council as being safe and beneficial for patients recovering from cancer treatment.19 The evidence for TC as an effective intervention for FSDSC is inconclusive from the research so far due to methodological limitations, including a high risk of selection bias and lack of blinding of the outcome assessor.20 Mixed results of effectiveness can be related to the quality of design and heterogeneity of dosage, including duration of TC interventions.21 This study’s methodology details a practical dose (frequency, duration, setting) of a specific TC form and uses established assessment tools, preparing the way for larger randomised control trials (RCTs).
Encouraging previous results from this research team indicate that TC can reduce symptoms such as fatigue, sleep disturbance and depression and can increase QoL and daily functioning.22 The Easy 8 Form of Yang Style TC was identified as suitable for BC survivors with FSDSC.23 A pilot RCT in two Chinese hospitals demonstrated that TC was an acceptable and effective adjunct therapy in China for patients with BC who were suffering FSDSC.22 24 This preliminary evidence encourages the implementation of this TC protocol to BC survivors in Australia.
However, there is no evidence yet of the acceptability of the Easy 8 Form TC in the Australian healthcare system. Cultural differences between China and Australia include the widely accepted practice of TC in China. This proposed research project aims to adapt the TC protocol and explore its feasibility, acceptability and preliminary effects as an adjuvant therapy in BC treatment in a regional Australian community setting. The research objectives are:
To refine and adapt the existing TC intervention from the Chinese hospital context to suit a regional Australian community context by undertaking a codesigned workshop to identify suitable adaptations.
To identify stakeholder perceptions of the feasibility and acceptability of the adapted TC intervention for BC survivors in regional Australia.
To conduct a preliminary evaluation of the adapted intervention using a single-group pre-post design to gather clinical data on fatigue, depression, sleep and QoL.
Method
Overall study design
The Medical Research Council (MRC) provides a framework to guide the evaluation of complex interventions in a health service.25 This project aligns with the first two phases of the MRC framework: developing an intervention and assessing its feasibility and evaluation design. Stage 1 will involve systematically adapting the TC intervention protocol to fit a regional community setting using an experience-based codesign (EBCD) approach26 27 to collaboratively explore what adaptations may be beneficial. Stage 2 will explore the adapted protocol’s feasibility, acceptability and evaluation design with a single-arm pre-post trial. This stage 2 trial will prepare for the possible future evaluation of the TC intervention effectiveness in a large-scale phase III RCT.
We have begun stage 1 to develop the adaptations, having collected some of the interview and focus group data and begun recruitment for the codesign workshop, which is anticipated to be conducted by early July 2026. Stage 1 data will then be analysed to inform the protocol for the TC to be used in the pilot trial. Recruitment for the pilot trial will be undertaken in July, and it is anticipated that the trial will be conducted from the end of August. The study data collection will be completed by the end of November 2026. The data will then be analysed and the findings written by May 2027.
The trial was prospectively registered (ACTRN12626000050358). The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guideline has been used to inform the reporting of this protocol manuscript28 (please see online supplemental file 1: SPIRIT Checklist), including items from the WHO Trial Registration Data Set (please see online supplemental file 2: Structured summary of the trial design and methods). The reporting of the codesign study will be guided by the Guidance for Reporting Involvement of Patients and the Public (GRIPP2) checklist as described in the supplementary document GRIPP2 checklist29 (please see online supplemental file 3: GRIPP2 checklist). An overview of the study design is shown in figure 1.
Figure 1. Overall study design.
Stage 1: adapting the TC protocol
The Easy 8 Form Yang Style TC intervention protocol,24 which was used in a recent phase II RCT within a Chinese hospital context, might not perfectly fit the Australian community context, as BC survivorship care in Australia usually occurs in the primary health sector, which differs from the healthcare and cultural context of the Chinese hospital study. Stage 1 uses an EBCD approach, combining a focus group, interviews and a codesign workshop, well suited to deeply explore the acceptability of the TC intervention and how it might be adapted to the local primary health sector.
Stage 1: study design
The steps of EBCD have been followed to capture experiences, understand the journey and codesign solutions (please see figure 2). Semistructured discussion with a focus group of women with lived experience of BC and semistructured interviews with a sample of BC healthcare providers (HCPs) will gather knowledge of BC survivorship care and the need for improving symptom management in the primary health sector. These methods of enquiry and collaboration bring useful information to guide the codesign of acceptable and feasible adaptations to the TC protocol in the codesign workshop. The results from the codesign workshop will guide the research team to make adaptations to the TC protocol to be trialled in stage 2.
Figure 2. Experience-based codesign steps. BC, breast cancer; TC, Tai Chi.
Stage 1: codesign setting
The codesign study will occur in a large regional town in northern Australia. The focus group and codesign workshop will be conducted in a community setting. The interviews will be conducted via video-conference link with the HCPs.
Stage 1: focus group
Sample
A small group of approximately six women from the Townsville region will be recruited to participate in this codesign project. A small size was selected to ensure lively discussion and deeper engagement. The inclusion criteria are as follows: (1) females at least 18 years old, (2) have been treated for BC or are the carer for BCS, (3) voluntarily consent to participate in the study, (4) not in a current treatment relationship with the researcher and (5) have sufficient English language skills to engage in the discussions. Exclusion criteria include (1) being younger than 18 years of age or (2) having a physical or mental condition that limits their capacity to participate in the study.
Procedure
All eligible women who are interested in participating in the codesign project will be given an information sheet in plain language to describe the aims of the study, what to expect when participating in the study and that an audio recording of the interview will be transcribed only for analysis. The recording will be deleted once a transcription has been made and checked for accuracy by an independent researcher. The information sheet clarifies that they will be volunteering and are free to withdraw at any time. Participants will sign an informed consent to participate before attending a focus group discussion at a local library for up to 90 min. For an example of all consent forms used in this study, please see online supplemental file 4. A semistructured focus group guide of discussion points will be used to explore participants’ experiences of FSDSC, their understanding of FSDSC and how they have been managing these symptoms, including experiences with exercise.
Data collection
The focus group discussion will be audio recorded, and its transcription will be deidentified. The transcription of the audio recording is used only for analysis of themes arising from each area in the semistructured discussion points and will be checked for accuracy by another member of the research team. A creative mind-mapping exercise will capture content, create connections and engage the participants in a shared narrative.
Data analysis
The deidentified transcriptions will be analysed using reflexive thematic analysis (RTA), an interpretive approach to identifying and analysing patterns or themes in the data.30 The mind map will be photographed, transcribed into NVivo and integrated into the thematic analysis. The themes and key points arising from the focus group will then be brought into the codesign workshop.
Stage 1: semistructured interviews with HCPs
Sample
A minimum of six local HCPs will be recruited to participate in the codesign project. This small sample of HCPs will include a sufficient breadth of perspectives by recruiting at least three of the following professions: breast care nursing, general practice, occupational therapy, physiotherapy, exercise physiology and psychology. Inclusion criteria are as follows: (1) current experience providing healthcare to BCS in a community setting, (2) voluntary consent to participating in the study and (3) have their employer’s support to participate in the study.
Procedure
HCPs will be recruited by direct emailing of a recruitment flyer to most primary HCPs in the Townsville region. Interested HCPs will be given an information sheet that includes a description of the aims and procedures of the interviews and codesign workshop. If eligible for the study, the HCPs will sign a consent form prior to a suitable time being arranged for the interview, which will be conducted via an online meeting platform or phone call. The discussion points for the semistructured interviews will be emailed to participants the day prior to the interview. After the interview, the TC protocol video will be emailed to the HCP for viewing and consideration prior to the codesign workshop.
Data collection
The interviews will be audio recorded, and the deidentified transcription of the audio recording will be checked for accuracy by an independent researcher.
Data analysis
Transcriptions will be used only for the analysis of themes arising from each area in the semistructured discussion points. These themes and key points will influence the inputs for the subsequent codesign workshop.
Stage 1: codesign workshop
Sample
Participants of the focus group and the HCPs interviewed will be invited to participate in the codesign workshop. A minimum of 6 and up to 12 participants will be included in the codesign workshop.
Procedure
Participants from the focus group and the HCP interviews will be brought together for a round-table discussion to share the gathered themes that are meaningful to the research questions on attitudes and perceptions of the barriers and facilitators of delivering TC to BCS in the primary health setting. The workshop will be held at a public library meeting room and will last up to 90 min. The codesign workshop will use prototyping exercises to creatively identify the best possible adaptations to the TC intervention to suit the local community context.
Data collection
The codesign workshop will be audio recorded, and the deidentified transcription of the audio recording will be checked for accuracy by an independent researcher. Knowledge of local resources will also be collected to create a contextual map of the community health setting for the pilot study.
Data analysis
The contextual map will inform the stage 2 setting, such as the selection of venues, identifying referral pathways and tailoring recruitment strategies. This study is exploratory of the experiences of the stakeholders and open-coded for RTA. Both semantic and latent coding will be used to capture meaningful information from the qualitative data that reflects both the content of respondent communication as well as deeper levels of meaning as interpreted by the researcher.
Stage 2: pilot trial with an embedded qualitative study of the adapted TC protocol
A pilot study of the adapted TC intervention will be conducted in stage 2 of this research project to assess the feasibility and acceptability of TC for BC-related FSDSC management using retention rates, adherence rates and qualitative feedback. The study will also make a preliminary evaluation of the intervention effects on the symptom cluster and QoL. It will be a pragmatic study of the participant experience of TC under usual conditions rather than controlled conditions. It is not yet known what adaptations will be designed in the workshop and incorporated in the TC protocol. However, if significant changes are made, a variation request will be submitted for ethics review and approval.
Stage 2: pilot trial study design
The single-group pre-post study is a simple, cost-effective approach to evaluating the feasibility and acceptability of healthcare interventions. Clinical outcome measures will be reviewed, and participant experiences will be assessed after the intervention to improve the protocol. In this study, the clinical changes are secondary to the qualitative analysis of adapting the intervention for the Australian community health context. However, the inclusion of pre-post measures will provide preliminary evidence of any clinical effect and establish the acceptability of using the outcome assessments, laying the foundation for further RCTs, which are required for stronger evidence of the benefits of TC for BC survivorship.
Stage 2: pilot trial setting
The pilot trial will be set in a community setting in a large regional city. A venue will be selected based on how a class might be able to continue there, such as a community space or an allied health facility.
Stage 2: pilot trial sample
A sample size of approximately 10 is typical for feasibility studies and sufficient to estimate feasibility parameters and generate preliminary effect size estimates. This sample size is not powered for hypothesis testing. Only female BC patients will be included in this pilot trial due to specific psychological and social impacts of BC that are unique to women, such as body image changes, menopause and motherhood, which are less relevant for men. The medical history of each participant’s BC experience will be collected during the assessment of their eligibility for the trial. The medical history collected will include their date of BC diagnosis, the type of BC, the current stage of their BC and the dates and types of treatment already experienced. Participants must provide a brief confirmation from their general practitioner (or treating specialist) that they are suitable for low–moderate intensity exercise (TC) prior to enrolment.
BCS will be included if they:
have been diagnosed with stage 1, 2 or 3 BC,
have completed adjuvant chemotherapy for BC for at least a month and up to 3 years,
have experienced at least a moderate level (at least 3/10) of tiredness, sleep disturbance and depressive mood in the previous month. The assessment of severity will follow the standards set for common symptoms in oncology.31
BCS will be excluded if they:
are currently using psychostimulants or hypnotic medications,
have elective surgery scheduled during the study period,
have stage 4 BC,
are unable to stand safely for 10 min,
have unstable medical conditions,
have a cognitive impairment preventing informed consent,
are involved with other exercise programmes greater than 30 min, three times weekly, for the past 3 months or have practised TC during the past 6 months, to reduce confounding.
Stage 2: pilot trial procedure
The pilot study of the adapted TC protocol will enrol and prepare suitable BCS, deliver the intervention, and then analyse the data (figure 3: Stage 2 pilot study). As this is a single-group pre-post study, randomisation of the sample or blinding to group allocation is not appropriate.
Figure 3. Stage 2 pilot study. TC, Tai Chi.
Participants will be recruited from a regional community in Queensland, Australia, through the distribution of flyers to participants in the codesign stage and other community networks. The flyers describe the study and provide contacts to register interest in participating. A printed information sheet will then be provided, describing the research aims and what she might expect to experience in the study. The planned start date for enrolment is anticipated to be the end of July 2026 and the final data collected by the end of November 2026. The timeline for the trial participants is described in table 1.
Table 1. Pilot trial participant timeline.
| Time point | Enrolment | T1 week 1 | T2 week 8 | T3 week 12 |
|---|---|---|---|---|
| Eligibility screen | X | |||
| Informed consent | X | |||
| Intervention | X | X | ||
| Outcome assessments | X | X | X | |
| Semistructured interview | X |
Screening for eligibility will occur in a discussion with the researcher to address both the inclusion and exclusion criteria. Once a BC survivor is deemed to be eligible to participate in the TC study and acknowledges she understands the information and agrees to participate in the study, the BC survivor will need to sign her informed consent to complete the enrolment process. When 10 women have been recruited, a start date will be confirmed with the venue and the participants.
The TC intervention commences at T1 and completes after 8 weeks at T2. The Easy 8 Yang TC form will be trained during the weekly group classes. The format of this trial intervention is based on a previously researched trial.29 The format of the adapted TC protocol (number and length of classes) will be refined based on the stage 1 workshop. However, it is anticipated that this intervention will comprise one 60 min class each week for 8 weeks. Each class will start with a 10 min warm-up with basic TC stretches and end with a 10-min cool-down of regulated breathing and meditation. During the practice session, a 5–10 min break will allow rest and social interaction.
Four self-report instruments will be administered to the participants in the pilot study: at baseline (T1), at the completion of the 8-week intervention (T2) and 4 weeks after the intervention (T3). The baseline clinical outcome measures will be collected from the pilot study participants in the week prior to the start of the trial. The intervention will be delivered as prescribed by the adapted TC protocol. At T2, the assessments are administered again along with a semistructured feedback interview with each participant. The third administration of the four assessments will occur 4 weeks post-trial at T3.
Attendance records will be kept of the classes, and participants will be encouraged to write in a reflective journal of their home practice to increase their recollection of their experience for the final feedback interview. In particular, it will be emphasised that they report any adverse impacts they might experience from practising TC. The retention rate, dropout rate and adherence rates are also to be recorded. Semistructured interviews with the TC study participants will be conducted after completion of the intervention. All the women who participate in the TC study will be asked to share their experience and offer suggestions and opinions at a final interview held after the TC course. The interview is to be an open-ended enquiry into their attitudes and perceptions of TC and how it may have changed during their participation. The participants’ ideas will be sought regarding barriers and enablers to using TC to manage BC symptoms. Information will be gathered on any perceived benefits they have noticed and how satisfied they were with participating in the trial. This will inform future iterations of the TC protocol.
Stage 2 pilot trial outcome measures
Primary outcomes
The primary outcomes of the pilot trial are the feasibility of providing TC in the primary health context and the acceptability of the refined TC intervention among BCS with FSDSC. The feasibility will be assessed by (1) the retention rate of participants remaining in the study to completion and (2) the outcome measure completion rate as the percentage of participants who successfully complete all the outcome measures, including the feedback interview. The acceptability will be assessed from attendance at the TC classes, the reasons for any non-attendance and the semistructured interviews conducted within a week after the last class.
Secondary outcomes
The secondary outcome measures used in this trial will be the self-report instruments used to assess the effectiveness of TC in managing FSDSC and improving QoL, as outlined in table 2 (see below). The self-report instruments used are the Brief Fatigue Inventory (BFI), the Hospital Anxiety and Depression Scale (HADS), the Pittsburgh Sleep Quality Index (PSQI) and the Functional Assessment of Cancer Therapy-Breast (FACT-B) quality-of-life instrument. They are easily administered, simply scored and quickly completed, making them suitable for patients who might be unwell or fatigued. The study’s focus on short-term feasibility guided the decision to collect the follow-up data 4 weeks after the end of the 8-week trial. Aside from indicating any preliminary clinical effect of TC, the acceptability and feasibility of using these outcome measures with BC patients will be explored in the postintervention interviews to guide further research involving larger RCTs.
Table 2. Self-report instruments.
Data management plan
The data management plan can be provided on request. The data will be collected and stored in accordance with the Australian Privacy Principles. Only necessary personal information will be collected, and its use will be limited. Participants will be informed about the collection and use of their data when signing the consent form. The consent includes permission to use the deidentified information in publication, presentation, teaching and further research. Personal identification information will be stored in a separate folder from the rest of the data. All data collected from participants will be deidentified by converting names to codes to be kept in a separate folder from the rest of the data. Statistical analysis of the group data for pre-post comparison to identify any preliminary signals of change in clinical outcomes will prevent individual identification.
No new data were created in the development of this protocol.
Quality assurance and data analysis
The trustworthiness and rigour of the qualitative research will be promoted via the following strategies.32 Credibility will be strengthened through ongoing team discussions and collaborative coding and interpretation, ensuring findings are grounded in participants’ perspectives rather than a single researcher’s view. Dependability will be supported by maintaining an audit trail that documents methodological and analytical decisions, providing transparency and consistency in the research process. Transferability will be enhanced through rich descriptions of the study context and participants, enabling readers to judge the applicability of findings to other settings. Confirmability will be supported through reflexivity and the audit trail, which help ensure findings are derived from the data rather than researcher bias. Confirmability will also be addressed via respondent validation of the themes within the subsequent codesign workshop.
The accuracy of information collected will be assured by at least two members of the research team verifying the authenticity of transcriptions and data coding. Transcriptions will be created using NVivo’s transcription service software from MP3 audio files. Transcriptions of the healthcare professionals’ interviews are to be created with either MS Teams or the Zoom platform. The accuracy of the transcriptions will be verified as authentic by a member of the research team. The transcripts will be thematically analysed using NVivo software and coded to capture meaningful information.
Descriptive statistics will be used to summarise the data collected in the study. For each outcome at T1, T2 and T3, we will report n, mean, SD, median, IQR, range and individual change scores. A descriptive data analysis of the feasibility of the TC intervention will use the participant retention rate (retention=number completing T3/number enrolled) and the adherence rate (adherence=number attending ≥X eight sessions/number enrolled). The total and subscale scores of the self-report instruments (BFI, PSQI, HADS and FACT-B) will be summarised for each time point by calculating the mean, the range and the SD. The amount, timing and reasons for missing data will be reported. Given the small feasibility sample, no imputation will be undertaken for the primary analysis.
The clinical outcome data will be statistically analysed using the SPSS 24.0 software package. Feasibility outcomes will be analysed using all enrolled participants; clinical outcome summaries will be presented for participants with available data at each time point, with completion status reported. Mean changes and standardised effect sizes from T1 to T2 and from T1 to T3 will be estimated with 95% CIs where appropriate. Findings will be interpreted as preliminary signals only. Cohen’s d standardised effect sizes with accompanying 95% CIs for all outcome measures will be calculated. Separately, mean changes will be compared with published minimal clinically important differences, and the proportion of participants achieving clinically meaningful improvement will be reported. Individual-level change will be explored using participant-level change scores, responder status and visual plots of trajectories across T1, T2 and T3. Quantitative change scores and clinically meaningful improvement status will be compared descriptively with qualitative interview themes to explore convergence, divergence and explanatory insights. Any contrasts may be investigated further with the participant for a deeper understanding of their experience. In addition, information from the feedback interview will be incorporated into the analysis of the feasibility and acceptability of both the intervention and the outcome measures.
Patient and public involvement
There has been no patient or public involvement in the development of this protocol. BCS and community clinicians will be involved in the codesign stage. They will explore barriers and facilitators to adapt the TC protocol prior to a feasibility trial commencing. Different BCS will participate in the pilot TC trial and provide feedback on their experiences related to the intervention and acceptability of the outcome measures selected for the study.
Ethics and dissemination
Ethical approval was granted by the Charles Darwin University Human Research Ethics Committee (H25108). Participants will be provided with written information about the study and the secure storage of data collected as detailed in the Data Management Plan. Results will be disseminated to the public via presentations and peer-reviewed publications and reported in the trial registry. A plain language aggregate, deidentified summary will be sent to participants within 3 months of publication acceptance.
Safety/adverse effects monitoring and risk mitigation plan.
We do not anticipate any significant risks from participating in this research. The pilot trial involves a low-to-moderate level of exercise capacity with movements that are potentially straining. Participants will be asked to acknowledge their functional capacity to stand unaided for 10 min before commencing the trial. The safety of all trial participants will be monitored with observation and enquiry during the classes. Appropriate first aid will be available, and support will be provided to access medical treatment if required. All adverse incidents will be documented, and the research team will review procedures to minimise recurrence. If an adverse event is reported, it would be fully investigated, the HREC would be notified, and appropriate actions would be taken alongside a decision about whether to stop the study.
Discussing cancer experiences may distress some participants. Psychological risk to participants will be managed using our Distress Protocol. During focus groups and interviews, the trained facilitator will actively monitor for distress and participants’ willingness to continue and offer to pause/skip topics or take a break. Participants can leave the session at any time without giving a reason. If distress is observed or reported, the facilitator is to provide immediate support and, if appropriate, offer referral options listed in the Participant Information Sheet (eg, GP, treating team, community mental health and national helplines). If a session ends early due to distress, the researcher is to follow-up with the participant later that day or the following morning to confirm safety and provide further options for support.
Discussion
Although recent meta-analyses have shown that a combination of aerobic and resistance exercise can reduce cancer-related fatigue (CRF)33 and improve QoL in women post-BC surgery,34 individuals who are fatigued or experiencing depression often face significant challenges to participate in any exercise regimen. Aside from the psychological and physical barriers, BCS in regional Australia often have limited access to exercise resources and support.
This study was designed to help address the challenges for BCS to exercise and seeks to learn ways to make TC a feasible and regular practice for women living with BC. This protocol outlines the codesign strategy for adapting an evidence-based TC protocol for BCS to suit a regional Australian primary health context. The study will also pilot the adapted TC intervention, incorporating qualitative and quantitative measures to evaluate the feasibility and acceptability of the intervention and the evaluation design. Qualitative outcomes will provide insight into the barriers and facilitators for implementing TC for BCS with FSDSC, as well as perspectives and knowledge regarding TC among local stakeholders.
Strengths and limitations
This protocol is unable to capture any longer-term impacts and experiences beyond 4 weeks post-trial. This limitation aligns with the study’s focus on assessing the acceptance and feasibility of the TC intervention for BCS and the selected data collection procedures. Eliminating BCS who are engaging in exercises may bias the sample towards less active individuals and may limit applicability to more active BCS.
Another limitation is the exclusion of caregivers from the pilot trial, even though their participation may improve the BCS’s motivation to attend classes and practise TC at home. Providing TC to caregivers may also bring health benefits to them, suggesting an area for further research. The brief TC form used in this study may underestimate the broader cognitive, emotional and embodied benefits of TC, as traditionally practised. The dosage of TC as a prescribed adjuvant intervention for BC health is more than the duration and frequency of practising TC. Traditional TC places importance on breath integration with the movements, sustained non-judgmental attention and interoception; however, these internal components are difficult to teach quickly and objectively measure. This study, however, is part of a staged approach to researching the benefits of TC for BCS, starting with a brief form of discrete movements suitable for a controlled trial environment and progressing on to more comprehensive TC protocols later.
This study is an early investigation of TC as an adjuvant intervention for BCS in Australia, in line with the National Health and Medical Research Council’s call for more robust trials evaluating the health benefits of TC.35 Additionally, it is the first Australian study on FSDSC in BCS and builds understanding of the symptom cluster. This protocol is strengthened by its reliance on established, evidence-based frameworks of MRC25 and EBCD.36 The EBCD framework systematically aligns the adaptations to the TC intervention with the preferences of the end-users. Situating the research within the context of regional Australian primary healthcare informs future research in similar settings. The inclusion of both qualitative and quantitative data measures enriches the understanding of the intervention’s impact.
Supplementary material
Footnotes
Funding: This study was funded by Australian Government Research Training Program Scholarship/10.82133/C42F-K220, DOI.
Prepublication history and additional supplemental material for this paper are available online. To view these files, please visit the journal online (https://doi.org/10.1136/bmjopen-2026-118474).
Provenance and peer review: Not commissioned; externally peer reviewed.
Patient consent for publication: Not applicable.
Patient and public involvement: Patients and/or the public were not involved in the design, conduct, reporting or dissemination plans of this research.
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